Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.
Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Gel will be sold in sterile packets for single patient/procedure, disposable use.
This sterile ultrasound gel 510(k) submission describes testing to support substantial equivalence to predicate devices. The acceptance criteria and supporting studies are outlined below:
1. Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:2009 Biocompatibility Standard | Meets ISO 10993-1:2009 for Irritation/Intracutaneous Toxicity and Sensitization. Cytotoxicity is equivalent to the predicate Sonotech's Natural Image Couplant. |
| Cytotoxicity | Equivalent cytotoxicity to predicate device | Equivalent to the cytotoxicity of Sonotech's Natural Image Couplant. |
| Irritation/Intracutaneous Toxicity | Meets ISO 10993-1:2009 standard | Meets ISO 10993-1:2009 standard. |
| Sensitization | Meets ISO 10993-1:2009 standard | Meets ISO 10993-1:2009 standard. |
| Bench Testing (Acoustic Performance) | Equivalent acoustical performance to predicate devices | Equivalent acoustical performance to the predicate Sheathing Technologies gel and to the UltraBio™ predicate gel. |
| Sound Velocity | Equivalent to predicate devices | Equivalent to predicate devices. |
| Acoustic Impedance | Equivalent to predicate devices | Equivalent to predicate devices. |
| Sound Attenuation | Equivalent to predicate devices | Equivalent to predicate devices. |
| Physical Measurements | Density and viscosity within the range measured in predicate devices | Density and viscosity are within the range measured in the predicate devices. |
| Density | Within range of predicate devices | Within the range measured in the predicate devices. |
| Viscosity | Within range of predicate devices | Within the range measured in the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test in the non-clinical studies (biocompatibility, bench testing, physical measurements). The data provenance is derived from laboratory testing of the device and comparison to predicate devices, rather than clinical patient data. Therefore, concepts like country of origin for patient data (as in medical image analysis) or retrospective/prospective clinical studies do not apply here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission pertains to a sterile ultrasound gel, an accessory, and its substantial equivalence is demonstrated through non-clinical laboratory testing and comparison to predicate devices, not through human interpretation of medical data. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The experts involved would be laboratory technicians, engineers, and quality assurance personnel performing and verifying the tests according to established international standards (like ISO 10993-1:2009). Their qualifications are typically in biomedical engineering, chemistry, biology, or related scientific fields, with expertise in laboratory testing and regulatory compliance.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1, 3+1) is relevant for studies where multiple expert readers assess the same cases and a consensus is needed to establish ground truth. As this submission focuses on objective laboratory and physical tests of a medical device accessory, such an adjudication method is not applicable. The "ground truth" for each test is established by the validated measurement methods and comparison against the characteristics of the legally marketed predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This type of study is relevant for evaluating the performance of AI-powered diagnostic devices where human reader performance is a key metric, and improvement with AI assistance is assessed. This submission is for an ultrasound gel, which is not an AI-powered diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone study (in the context of an algorithm's performance without human interaction) was conducted. The device is a physical product (ultrasound gel), not an algorithm. Its performance is entirely standalone in the sense that it functions as a coupling agent for ultrasound, and its physical and acoustic properties are measured directly.
7. Type of Ground Truth Used
The ground truth used for this submission is based on:
- Established International Standards: For biocompatibility, the ISO 10993-1:2009 standard serves as the benchmark.
- Predicate Device Characteristics: For acoustic performance and physical measurements (density, viscosity), the characteristics of legally marketed predicate devices (Sonotech Clear Image™ Sterile Scanning Gel, K931909; Sheathing Technologies Ultrasound Gel, K112827; Sonotech UltraBio™ Sterile Ultrasound Imaging Couplant, K042619) serve as the "ground truth" or reference for substantial equivalence. The new device's performance is compared directly to these established products.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device accessory and does not involve AI or machine learning. Therefore, there is no training set.
9. How the Ground Truth for the Training Set was Established
Since there is no training set for an AI/machine learning algorithm, this question is not applicable.
Ask a specific question about this device
Page 1 of 1